Announcer: From the National Institutes of Health in Bethesda, Maryland, this is All About Grants.

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Megan Columbus: Hello and welcome to another edition of All About Grants. I’m your host Megan Columbus, Acting Director of Communications and Outreach in NIH’s Office of Extramural Research. Today we will be discussing NIH’s New and Early Stage Investigator Policies. I have with me Dr. Wally Schaffer, who I’d like to welcome to the show today. Hello.

Wally Schaffer: Hi Megan. Thanks for inviting me.

Megan: Dr. Wally Schaffer is Senior Scientific Advisor for Extramural Research for NIH. He has also been associated with NIH career development and training for many years. Wally, I know that NIH has had a long-standing interest in new investigators. Can you tell us a little bit about historical policies around them and our support of them?

Wally: Sure, I’ll give it a shot. I’ve been at the NIH for a long time but these policies really pre-date me. The first new investigator award was started in 1977 for the same reason that we have new investigator policies right now. There was concern about the declining entry of new investigators into the NIH portfolio of principal investigators. And so the NIH in 1977, started this new investigator research award commonly referred to as the NIRA, and it was a 3-year award, for $35,000 per year. And by 1988, the NIH figured out that that wasn’t enough for people to get started. A lot of the folks that were getting those awards weren’t going on to subsequent research. In other words, they weren’t staying in our system. So in 1988, the NIH abandoned the NIRA award and started the FIRST award — F-I-R-S-T. And the FIRST award was much larger. It was $250,000 a year for five years, and the NIH stuck with that. They seemed to be working until 10 years later when in 1998 they again looked at it and felt that it wasn’t enough money and it wasn’t launching careers. And some of those investigators weren’t proceeding on to the traditional NIH research grant, an R01.

Megan: And so they did away with the FIRST award as well?

Wally: They did away with the FIRST award, that’s right. And they replaced it with a check box on the face page of our grant applications — you may remember that. So new investigators would identify themselves when they came in, and we actually gave them certain incentives. In other words, we looked at them very carefully in the review process and also at the time of funding. But there were some problems with that particular policy, and one of them was that investigators frequently misidentified themselves as new investigators. There were type 1 and type 2 errors. In other words, people got it wrong in both directions, and, in about 2004, it was decided that we would start indentifying new investigators based on whether they have appeared as a recipient of a substantial, competing research grant in our system. And so we used software — a software approach — and we also stopped, narrowed the kinds of research grants where we would offer those types of advantages to make sure that people had a long enough period of support initially, as well as enough money in order to get their careers going and come back with something after their initial award. And so we limited it to R01s, and then we noticed that the age of investigators and period of training was increasing, so we started this new policy called ESIs, which I will talk about in a few minutes.

Megan: And so the ESI policy – that early stage investigator policy you referred to as ESI — you are saying that new investigators are becoming new investigators later and later in life?

Wally: Yes, so what we found out was that age at which someone got their first award was gradually increasing, and it was increasing at about 0.2 years per year. For a long period of time, the whole population of new investigators was becoming older and older, and there was concern about that. You know, people have frequently pointed to greater rates of innovation at younger ages and so forth. And there was concern that the advancement to independence, being delayed as it was, might inhibit some of that. So we developed the Early Stage Investigator policy that would allow us to recognize people that were a little bit younger. And it’s really not about age per se, but it’s about the duration of training leading up to independence. What we found was that the age at which people received their terminal research degree had been fairly stable for maybe a decade at about 32 years of age, or about seven years after the baccalaureate people would receive their Ph.D.s. So what we determined was that most of the increase in average age was due to longer periods of postdoctoral training. And so the Early Stage Investigator policy is really directed at trying to reduce that period of postdoctoral training. To put incentives in so that principal investigators will move along and institutions will find them a little more attractive and will hire them into faculty positions at an earlier rate.

Megan: So the ESI policy, how does that relate to the New Investigator policy? Does the New Investigator policy still stand?

Wally: ESIs are a particular type of new investigator. In other words, we look at early stage investigators — people that haven’t — it’s part of the new investigator pool — in other words they haven’t had a substantial grant from the NIH previously and they are also within 10 years of their terminal research degree or within 10 years of finishing their medical residency.

Megan: But we still have a new investigator pool that doesn’t fit the ESIs.

Wally: That’s correct.

Megan: And do they still get special consideration?

Wally: We still include those in some of our targets, and we provide special considerations. So, in other words, yeah, the incentives apply to new investigators and the incentives are as follows. Right now, we identify applications from new investigators at the time they come in the door. And then we tend to cluster them at the review meeting so that reviewers can determine which applications from new investigators are most meritorious – oftentimes new investigators will have — an application — has less preliminary data than somebody who has been experienced and has been working in the field and has been awarded grant support in the past.

Megan: And the reviewers are given instructions in terms of what they should expect from the new investigators?

Wally: That’s correct. They would expect less preliminary data. They would be able to look more carefully at the training and their productivity during their training period of their careers, which may be in different projects that may not be as closely related to the project that is proposed in their application. So they judge them accordingly. And it allows us and it allows the reviewers to pick those applications that are the most promising from those new investigators and then they score them. And then the second part of that has to do with incentives that the Institutes and Centers provide at the time of selecting applications for funding. In other words, they will look at the scores but right now our policy is such that the — NIH or the — Office of the Director directs each of the Institutes and Centers to try to equalize the success rate for new investigators — the pool of applications from new investigators — with the pool of applications from experienced investigators submitting new proposals, in other words, type 1 applications. And so by equilibrating that success rate, we’ve determined that we can approximate certain numerical targets that provide a flux rate of new investigators into the pool of funded principal investigators that is just about appropriate.

Megan: And that ensures the pipeline continues?

Wally: Right. In terms of setting some numerical targets — success rate targets — we started that I think in 2004. If you look at the data that’s displayed on our Web site, you can see that the number and proportion of new investigators has gone up. In 2009, we had the highest rate of new investigators entering our system as a recipient of R01s and the highest proportion that we have had in more than 20 years.

Megan: So the difference, in terms of the benefits, that a new investigator versus a new investigator who is also an early stage investigator, are the targets different?

Wally: Well, the targets are the same. In other words, we have targets, numerical targets, for new investigators, and then we specify that at least half of that new investigator pool needs to be within the early stage of their career, so within 10 years of their terminal research degree or 10 years of finishing their medical residency. And I should point out, I know you haven’t asked this, but I should point out that we make allowances for lapses in peoples careers in terms of the early stage policy. In other words, if people have had to take time off from research for family care, or they have been ill, or they have a disability, or they’ve had extended periods of clinical training like a specialty or subspecialty fellowship, or they’ve been in the military and had a military obligation, we will extend that 10-year period to accommodate those kinds of things.

Megan: Great.

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Announcer: For more information on how to request an extension, visit grants.nih.gov and search “ESI extension.”

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Megan: So we are back with Dr. Wally Schaffer talking about early stage investigator policies. Wally, you’ve certainly talked a lot about the policy, and the history of the policy, how would someone identify themselves as a new investigator?

Wally: They do this when they create their Commons profile. In other words, in order to be a principal investigator, on any grant at the NIH, you have to create a Commons profile.

Megan: And so the Commons is NIH’s electronic interface with our applicant community.

Wally: That’s right. And the signing official or some other official at the institution will set up an account to allow people to register in the Commons.

Megan: Okay, and the Commons I believe can be found at eRA.nih.gov for those who aren’t familiar with it.

Wally: Okay, I’ll take your word for that.

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Wally: Within the Commons pages, there are — there is a place for — there is a page on which you can enter the date of your last terminal degree. And also on that page there is software that calculates and goes back and determines whether or not you’ve had a substantive NIH grant in the past and will display on that page whether you are a new investigator or not.

Megan: And so that is within the personal profile of the investigator?

Wally: That’s exactly right. So on that page, almost in real time, you can determine whether or not you’re a new investigator. It will be displayed there. And once you enter the date it will calculate a window for your eligibility as an early stage investigator, and it’s usually 10 years from the completion of your terminal research degree or 10 years from the completion of your medical residency.

Megan: So what should someone do if they put in their information and the system does not correctly identify them?

Wally: They should get in touch with the helpdesk

Megan: Okay, that would be the eRA Commons helpdesk?

Wally: That’s correct.

Megan: And we’ll provide some contact information for that at the end of the show.

Wally: That’s right. And most of the time that works. Occasionally it doesn’t work or if people have questions, the helpdesk will be able to help them with that.

Megan: You had said in the earlier segment that we have provisions that allow for extensions for people who have had to take time off for various reasons. How would somebody go about requesting one of those extensions?

Wally: Okay, so if there is the need for an extension, you can go on to the New and Early Stage Investigator Web site, and it’s clearly marked, there is a little box on that page that indicates how you would request an extension. It creates an e-mail to the NIH and allows you to indicate the parameters that a small committee will need to look at in order to grant that extension. And it allows you to describe the situations that may have resulted in a lapse in your research training or a lapse in your research career, you know, associated with family care responsibilities, illness, disability and other factors.

Megan: And I understand that many of those are approved.

Wally: Many are approved. I think about three-quarters of them are approved.

Megan: That’s good news. Are there special opportunities for new investigators that you might recommend that people look at?

Wally: Well in addition to being identified as a new investigator and getting the incentives for the receipt of an R01 grant that new investigators and early stage investigators enjoy, there are also some other programs that new investigators might want to look at. For example, there is the new Director’s New Innovator Award, which is a special award that only new investigators can apply for. And there is also the Pathway to Independence Award, which is a combined career award/research grant. So in other words, somebody who is in the terminal stages of their postdoc career can apply for a K99/R00. And the K99 part will support the final years of their postdoctoral experience, and the R00 part will be a transition — help with the transition — to an independent position.

Megan: So it sounds like there lots to explore for new investigators

Wally: That’s right. And most of the stuff, as I have indicated before, is on the New and Early Stage Investigators Web site.

Megan: Great, well thank you very much for coming with us today. That wraps up today’s edition of All About Grants. I’d like to thank Dr. Wally Schaffer for joining us today. Tune in next time. For NIH and OER, I’m Megan Columbus.